[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602285":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":17,"locations":26,"responsibleParty":40,"collaborators":43,"id":47,"slug":48,"hasResults":49,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":10,"eligibilityCriteria":52,"healthyVolunteers":49,"sex":53,"minAge":10,"maxAge":54,"enrollmentInfo":55,"targetDuration":58,"studyType":59,"phases":10,"briefSummary":60,"conditions":61,"keywords":68,"overallStatus":29,"whyStopped":10,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Karolinska Institutet","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Children with tracheostomy undergoing at LIVA",null,"All children under 18 years with tracheostomy undergoing follow-up through the long term intensive care unit LIVA at Karolinska University Hospital Solna, Sweden will be eligible for inclusion. This is a majority of the children living with tracheostomy in Sweden.",[13],{"name":14,"affiliation":15,"role":16},"Ida Engqvist, MD","LIVA, Barn PMI, Karolinska Universitetssjukhuset, Solna, Sweden","PRINCIPAL_INVESTIGATOR",[18,22],{"name":14,"role":19,"phone":20,"phoneExt":10,"email":21},"CONTACT","+46(0)768455333","ida.engqvist@regionstockholm.se",{"name":23,"role":19,"phone":24,"phoneExt":10,"email":25},"Eva Hedlund, MD, PhD","+46(0)707421285","eva.h.hedlund@regionstockholm.se",[27],{"facility":28,"status":29,"city":30,"state":10,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":10},"LIVA, Barn PMI, Karolinska Universitetssjukhuset Solna","RECRUITING","Solna","17176","Sweden","SE",{"type":35,"coordinates":36},"Point",[37,38],18.00086,59.36004,{"lat":38,"lon":37},{"type":16,"investigatorFullName":41,"investigatorTitle":42,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Ida Engqvist","Medical doctor, Principal Investigator",[44],{"name":45,"class":46},"Region Stockholm","OTHER_GOV","100602285","airway-complications-in-pediatric-patients-with-tracheostomies-to-what-extent-can-symptoms-identified-by-caregivers-or-pediatricians-serve-as-predictors-for-airway-complications-confirmed-through-surveillance-endoscopy-100602285",false,"NCT07121517","\"Airway Complications in Pediatric Patients With Tracheostomies: To What Extent Can Symptoms Identified by Caregivers or Pediatricians Serve as Predictors for Airway Complications Confirmed Through Surveillance Endoscopy?\"","Inclusion Criteria:\n\nAll children, with tracheostomy, under the age of 18, undergoing scheduled surveillance airway endoscopy in anaesthesia as part of their regular follow-up at the Long term Intensive Care unit (LIVA) at Karolinska University Hospital are eligible for inclusion. Patients may be included several times during the study period.\n\nExclusion criteria:\n\nAll patients undergoing airway endoscopy that is not part of the surveillance airway endoscopy program will be excluded. Thus, emergency endoscopies are not included in this study.","ALL","18 Years",{"count":56,"type":57},100,"ESTIMATED","2 Years","OBSERVATIONAL","Study Objective:\n\nThis observational study aims to prospectively investigate to what extent tracheostomy-related complications in children are asymptomatic or associated with symptoms when detected through surveillance airway endoscopy. We also aim at investigating how reliable caregiver reports and investigations by pediatriscians are in identifying symptoms associated with severe tracheostomy-related airway complications.\n\nStudy Population:\n\nThe study population comprises children under 18 years of age undergoing follow-up at the Long-Term Intensive Care Unit (LIVA) at Karolinska University Hospital in Stockholm, Sweden.\n\nResearch Questions:\n\n1. To what extent are tracheostomy-related complications in children asymptomatic when detected through surveillance airway endoscopy?\n2. How reliable are caregiver reports in identifying symptoms associated with tracheostomy-related airway complications?\n\nMethods:\n\nChildren scheduled for surveillance airway endoscopy are admitted to LIVA. Upon admission, the caregiver is asked to complete a short questionnaire regarding symptoms that may indicate a tracheostomy-related complication.\n\nAfter the questionnaire has been completed, the child will be examined by the responsible paediatrician, with the aim of identifying any signs or symptoms that could indicate an airway complication. The examination includes physical examination and medical history conducted according to a predefined protocol.\n\nThe airway endoscopy is performed by an ENT surgeon who has not examined the patient beforehand and is not informed of the caregiver's responses nor the result of the examination by the pediatrician. However, there is no strict protocol in place to blind the surgeon to any visibly apparent symptoms or to information that may be spontaneously reported by the caregiver or paediatrician.",[62,63,64,65,66,67],"Surveillance","Endoscopy","Tracheostomy Complication","Tracheostomy Complications","Tracheostomy","Children in the Pediatric Intensive Care Unit or General Pediatric Care Unit Requiring a Central Venous Catheter",[69,70,71,72,73],"surveillance","endoscopy","pediatric","intensive care unit","tracheostomy complication","2026-02-12",{"date":76,"type":77},"2026-02-17","ACTUAL",{"date":79,"type":77},"2025-09-01",{"date":81,"type":57},"2027-08-31",{"name":5,"class":6},1]